Trial Outcomes & Findings for Botox Cosmetic and the Young Patient With Glabellar Furrows (NCT NCT00856999)

Results Overview

Four-point validated facial wrinkle scale (FWS) Minimum score = 0 (no wrinkles) Maximum score = 3 (deep wrinkles) Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

26 months

Results posted on

2019-07-23

Participant Flow

Recruited from medical practice and IRB approved media placement

Participant milestones

Participant milestones
Measure	Botox Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups Botox: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
Overall Study STARTED	50
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Botox Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups Botox: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botox n=50 Participants Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups Botox: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
Age, Categorical <=18 years	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=50 Participants
Sex: Female, Male Female	50 Participants n=50 Participants
Sex: Female, Male Male	0 Participants n=50 Participants
Region of Enrollment United States	50 participants n=50 Participants
Facial wrinkle scale	2.78 units on a scale n=50 Participants

PRIMARY outcome

Timeframe: 26 months

Four-point validated facial wrinkle scale (FWS) Minimum score = 0 (no wrinkles) Maximum score = 3 (deep wrinkles) Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase

Outcome measures

Outcome measures
Measure	Treatment n=50 Participants 26-month 2-phase study enrolling 50 toxin-naïve females aged 30-50 years with Fitzpatrick Skin Types I to III and moderate (2) to severe (3) glabellar lines on the 4-point Facial Wrinkle Scale at maximum contraction.
Reduction of the Facial Wrinkle Scale Physician Rating	1.86 units on a scale Standard Deviation 0.65
Reduction of the Facial Wrinkle Scale Subject Rating	2.10 units on a scale Standard Deviation 0.67

PRIMARY outcome

Timeframe: 20 months

Four-point satisfaction scale Neutral = 0 (minimum score) Somewhat satisfied = 1 Definitely satisfied = 2 Greatly satisfied = 3 Couldn't be more satisfied = 4 (maximum score) Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase

Outcome measures

Outcome measures
Measure	Treatment n=50 Participants 26-month 2-phase study enrolling 50 toxin-naïve females aged 30-50 years with Fitzpatrick Skin Types I to III and moderate (2) to severe (3) glabellar lines on the 4-point Facial Wrinkle Scale at maximum contraction.
Patient Assessed Frown-line Improvement Score 0	7 percentage of patients
Patient Assessed Frown-line Improvement Score 1 to 2.5	24 percentage of patients
Patient Assessed Frown-line Improvement Score 3 to 4	69 percentage of patients

Adverse Events

Botox

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roger Dailey, MD, FACS

Oregon Health & Sciences University

Phone: 503-494-3020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place